[Ilse Snieders]

Hello, at our hospital in the Netherlands there is some discussion about filing CVs due to privacy legislation. Some departments want to stop with sending CVs of the study team to sponsors, only keep them up to date on site and only give the CV of the Principal Inevestigator to the sponsor for archiving in the TMF (so one CV per site).
Is there someone who knows if CVs of the study team need still to be in the sponsor’s TMF according to current legislation?

Kind regards, Ilse

[Ilse Snieders]

Interesting question, I would like to hear from someone about this with experience with eTMFs.

At our hospital, we only file final / superseded versions and clean up before final long term archiving (i.e. check on work/interim versions in between which can be deleted).

Regards, Ilse

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